A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers

Early Phase 1CompletedNCT07090655

Climb Bio, Inc.30 enrolled

Overview

The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers.

Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of budoprutug administered subcutaneously (SC) in adult normal healthy volunteers (NHVs). To assess the bioavailability of the SC formulation, one cohort will receive a single intravenous (IV) dose of budoprutug. Approximately 38 participants will be enrolled across four dose cohorts, including three SC dose levels and one IV comparator group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

BudoprutugDRUG

Subcutaneous or IV administration

PlaceboDRUG

Placebo comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adult males and females aged 18-60 years * Body mass index (BMI) between 18 and 32 kg/m² and weight between 45 and 110 kg * Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant) * Willing and able to comply with study procedures and provide informed consent * Women of childbearing potential must use highly effective contraception and have negative pregnancy tests * Men must use contraception and refrain from sperm donation for 6 months post-dose * Completion of a 2-dose primary COVID-19 vaccination series and at least 1 booster dose, as well as influenza vaccination (within 12 months) Exclusion Criteria: * Prior treatment with investigational drugs within 30 days or 5 half-lives * History of hypogammaglobulinemia or significant allergic reactions * Recent infections, including serious local/systemic infections or opportunistic infections * Positive tests for HIV, hepatitis B/C, syphilis, or tuberculosis * Use of tobacco (\>2 cigarettes/day), alcohol abuse, or recreational drugs * Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)

Locations (1)

Nucleus Network Brisbane

Brisbane, Australia

Outcomes

Primary Outcomes

Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants

Incidence of treatment-emergent adverse events

Time frame: Day 57

Incidence of infusion-related reactions (IRRs) for IV administration

Number of infusion-related reactions

Time frame: Day 57

Incidence of injection site reactions (ISRs) for SC administration

Number of injection site reactions

Time frame: Day 57

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Measurement of the maximum observed plasma concentration.

Time frame: Day 57

Time to Maximum Observed Concentration (Tmax)

Measurement of the time to maximum observed concentration.

Time frame: Day 57

Area Under the Curve (AUC)

Measurement of the area under the drug concentration-time curve.

Time frame: Day 57

Terminal Half-Life (T1/2)

Measurement of the terminal half-life in days.

Time frame: Day 57

Bioavailability (F)

Relative absorption of SC vs IV budoprutug (%).

Time frame: Day 57

Data from ClinicalTrials.gov

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